Day

October 1, 1998
10/1/98 Class II Quinton Q-Cath Hemodynamic Analysis System 81 units. Units with version 4.5 software. Device has potential to display previous patient’s blood pressure. Z-855/859-9
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9/4/98 Nera Electronics/Baxter Healthcare Flo Gard 8200 Volumetric Infusion Pump: Class II 13 units. Board assemblies had the wrong software version installed on them. The boards have version 2.09 instead of version 2.13. Recall #=-Z-777-8.
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Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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